Saliva direct cup - royal medical supplies pty ltd, sydney australia

Saliva Direct Cupsize: Kit Oral Fluid DrugtestTHC - COC - OPI - MET - AMP - BZDTHC - COC - OPI - MET - AMP - MTDAll Kits come Security Seal for eitherthe Sample Cup or theresealable Device BagSaliva Direct CupOral Fluid Drugtest Saliva Direct CupOral Fluid Drug Test
Professional judgment should be applied to
Product Insert / Instructions
any drug of abuse test result, particularly
when preliminary positive results are indica-
Package Insert for the
SUMMARY AND EXPLANATION OF TESTTHC - COC - OPI - MET - AMP - BZD
The SalivaScreen Oral Fluid Drug Test Device
for AMP/MET/COC/OPI/THC/BZD/MTD and
*THC - COC - OPI - MET - AMP- MTD
their metabolites is a rapid, oral fluid scree-
ning test that can be performed without the
Test for Oral Fluids
use of an instrument. The test utilizes mono-
clonal antibodies to selectively detect elevated
A rapid, screening test for the simultaneous,
levels of specific drugs in human oral fluid.
qualitative detection of Amphetamine,
Marijuana, Benzodiazepine, Methadone
AMPHETAMINE (AMP) - 50 ng/mL
and their metabolites in human oral fluid.
For professional and in-vitro diagnostic use only.
Amphetamine is a sympathomimetic amine
with therapeutic indications. The drug is often
selfadministered by nasal inhalation or oral
INTENDED USE
Depending on the route of administration,
The SalivaScreen Oral Fluid Drug Test Device
Amphetamine can be detected in oral fluid as
for AMP/MET/COC/OPI/THC/BZD/MTD is a
early as 5-10 minutes and up to 72 hours after
lateral flow chromatographic immunoassay for
the qualitative detection of Amphetamine,
The Amphetamine assay contained within the
SalivaScreen Oral Fluid Drug Test Device
yields a positive result when the Amphetamine
concentration in oral fluid exceeds 50 ng/mL.
Amphetamine (AMP)
METHAMPHETAMINE (MET) - 50 ng/mL
D-Methamphetamine
Methamphetamine is a potent stimulant chemi-
cally related to amphetamine but with greater
CNS stimulation properties. The drug is often
selfadministered by nasal inhalation, smoking
or oral ingestion. Depending on the route of
11-nor-∆9-THC-9 COOH
administration, methamphetamine can be
Benzodiazepine (BZD)
detected in oral fluid as early as 5-10 minutes
and up to 72 hours after use.
Methamphetamine, Cocaine, Opiates,
The Methamphetamine assay contained within
Marijuana, Benzodiazepine, Methadone and
the SalivaScreen Oral Fluid Drug Test Device
their metabolites in oral fluids at the following
yields a positive result when the Methamphe-
cut-off concentrations:
tamine concentration in oral fluid exceeds 50
This assay provides only a preliminary analyti-
COCAINE (COC) - 20 ng/mL
cal test result. A more specific alternate che-
mical method must be used in order to obtain
Cocaine is a potent central nervous system
a confirmed analytical result. Gas chromato-
(CNS) stimulant and a local anesthetic derived
graphy/mass spectrometry (GC/MS) and gas
from the coca plant (erythroxylum coca). The
chromatography/tandem mass spectrometry
drug is often self-administered by nasal inha-
(GC/MS/MS) are the preferred confirmatory
lation, intravenous injection and free-base
smoking. Depending on the route of admini-
Saliva Direct CupOral Fluid Drugtest
stration, cocaine and metabolites benzoylecgo-
BENZODIAZEPINES (BZD) - 50 ng/mL
nine and ecgonine methyl ester can be detected
in oral fluid as early as 5-10 minutes following
Benzodiazepines are frequently prescribed
use. Cocaine and benzoylecgonine can be
sedative and hypnotic drugs for the symptoma-
detected in oral fluids for up to 24 hours after
tic treatment of anxiety, insomnia, sleep and
seizure disorders. Most Benzodiazepines are
The Cocaine assay contained within the
extensively metabolized in the liver and excre-
SalivaScreen Oral Fluid Drug Test Device
ted in the urine and saliva as metabolites.
yields a positive result when the cocaine meta-
Chronic abuse may increase the risk of physi-
bolite in oral fluid exceeds 20 ng/mL.
cal dependence and may result in intoxication,
drowsiness and muscle relaxation. Oxazepam
OPIATE (OPI) - 40 ng/mL
is the major metabolic product of
Benzodiazepines. The Benzodiazepines assay
The drug class opiates refers to any drug that is
contained within the SalivaScreen Oral Fluid
derived from the opium poppy, including natural-
Drug Screen Device yields a positive result
ly occurring compounds such as morphine and
when the concentration of Oxazepam in oral
codeine and semi-synthetic drugs such as
fluids exceeds 50 ng/mL.
heroin. Opiates act to control pain by depres-
sing the central nervous system. The drugs
METHADONE (MTD)
demonstrate addictive properties when used for
Under development
sustained periods of time; symptoms of withdra-
wal may include sweating, shaking, nausea and
irritability. Opiates can be taken orally or by
Under special request
injection routes including intravenous, intramus-
cular and subcutaneous; illegal users may also
take the intravenously or by nasal inhalation.
Using an immunoassay cutoff level of 40 ng/mL,
codeine can be detected in the oral fluid within
The SalivaScreen Oral Fluid Drug Test Device
1 hour following a single oral dose and can
for AMP/MET/COC/OPI/THC/BZD is an immu-
remain detectable for 7-21 hours after the dose.
noassay based on the principle of competitive
6-monoacetylmorphine (6-MAM) is found more
binding. Drugs that may be present in the oral
prevalently in oral fluid, and is a metabolic pro-
fluid specimen compete against their respecti-
duct of heroin. Morphine is the major metabolic
ve drug conjugate for binding sites on their
product of codeine and heroin, and is detectable
specific antibody. During testing, a portion of
for 24-48 hours after an opiate dose. The
the oral fluid specimen migrates upward by
Opiates assay contained within the Oral Fluid
capillary action. A drug, if present in the oral
Drug Test Device yields a positive result when
fluid specimen below its cut-off concentration,
the concentration of Morphine in oral fluid
will not saturate the binding sites of its speci-
exceeds the 40 ng/mL cut-off level.
fic antibody. The antibody will then react with
the drug-protein conjugate and a visible colo-
MARIJUANA (THC) - 12 ng/mL
red line will show up in the test line region of
the specific drug strip. The presence of drug
Tetrahydrocannabinol, the active ingredient in
above the cut-off concentration in the oral fluid
the marijuana plant (cannabis sativa), is detec-
specimen will saturate all the binding sites of
table in saliva shortly after use. The detection of
the antibody. Therefore, the colored line will
the drug is thought to be primarily due to the
not form in the test line region. A drug-positive
direct exposure of the drug to the mouth (oral
oral fluid specimen will not generate a colored
and smoking administrations) and the subse-
line in the specific test line region of the strip
quent sequestering of the drug in the buccal
because of drug competition, while a drug-
cavity. Historical studies have shown a window
negative oral fluid specimen will generate a
of detection for THC in saliva of up to 14 hours
line in the test line region because of the
after drug use. The Marijuana assay contained
absence of drug competition. To serve as a
within the SalivaScreen Oral Fluid Drug Test
procedural control, a colored line will always
Device yields a positive result when the
appear at the control line region, indicating
11-nor-∆9-THC-9 COOH concentration exceeds
that proper volume of specimen has been
added and membrane wicking has occurred.Saliva Direct CupOral Fluid Drugtest DIRECTIONS FOR USE
The test contains membrane strips coated with
Allow the test device to reach room temperatu-
drug-protein conjugates (purified bovine albu-
re [15-30°C] prior to testing. Do not place
min) on the test line, a goat polyclonal antibo-
anything in the mouth including food, drink,
dy against gold-protein conjugate at the con-
gum, mints or tobacco products for at least 10
trol line, and a dye pad which contains colloi-
minutes prior to collection of oral fluid speci-
dal gold particles coated with mouse monoclo-
nal antibody specific to Amphetamine,
1. Bring the pouch to room temperature before
Morphine, 11-nor-∆9-THC-9 COOH and
opening it. Remove the test from the sealed
pouch and use it as soon as possible.2. Remove the test device from the sealed
• For professional use only.
• Do not use after the expiration date.3. Insert the sponge end of the collection device
• The Oral Fluid Drug Test Device should
into the mouth. Close mouth and gently
remain in the sealed pouch until use.
chew the sponge for saliva excretion. Soak
• Saliva is not classified as biological hazard
sponge into saliva in mouth and swab the
unless derived from a dental procedure.
inside of the mouth, tongue and cheeks to
• The used collector device should be
collect oral fluid for approximately 3 minutes
discarded according to federal, state
until the sponge becomes completely soft
and/or local regulations.
and fully saturated with saliva. No hard spots
should be felt on the sponge when saturated.STORAGE AND STABILITY4. Remove the collection device from the mouth.
Store as packaged in the sealed pouch at 2-
With gentle pressure, place the collection
30°C. The test is stable through the expiration
device with the saturated sponge into the
date printed on the sealed pouch. The test
Collection Chamber.
devices must remain in the sealed pouch until
5. Screw the Collector Cap clockwise to secu-
use. DO NOT FREEZE.
re the cap tight and start the timer.
SPECIMEN COLLECTION AND6. Mark patient ID on the test device. Peel off
the label to read test results. Wait for the
color line(s) to appear on the test strips.
The oral fluid specimen should be collected
Read results at 10 minutes.
using the collection device provided in the kit.
Do not read results after 1 hour.
Follow the detailed directions for use below.
No other collection devices should be used
7. Send the collector with collected oral fluid
with this assay. Oral fluid collected at any time
to the laboratory for GC/MS confirmation if
of the day may be used.
necessary. (if needed for confirmation)
Materials Materials Provided
• Package insert
Materials Required But Not Provided:Saliva Direct CupOral Fluid Drugtest
(hard, imbued with
ascorbic acid for
better saliva flow)
1 Remove collection device from test cylinder2 Place the collection device/sponge in donors mouth andmove over the tongue and into both cheeks to collect asmuch saliva as possible. Repeat for approx. 3 minutes.3 Place collection device back in cylinder and tighten cap4 Read results at approx. 5 minutesSecure the saliva sample withYou can seal the pouch. .or the Collection ChamberINTERPRETATION OF RESULTS
(Please refer to the previous illustration)
POSITIVE: One color line appears in the con-
trol region (C). No line appears in the test
NEGATIVE: Two lines appear. * One color line
region (T). This positive result indicates that
should be in the control region (C), and anot-
the drug concentration is above the detectable
her apparent color line adjacent should be in
the test region (T). This negative result indica-
INVALID: Control line fails to appear.
tes that the drug concentration is below the
Insufficient specimen volume or incorrect pro-
detectable level.
cedural techniques are the most likely reasons
*NOTE: The shade of color in the test line
for control line failure. Review the procedure
region (T) will vary, but it should be conside-
and repeat the test using a new test device. If
red negative whenever there is even a faint
the problem persists, discontinue using the lot
distinguishable color line.
immediately and contact your supplier.Saliva Direct CupOral Fluid Drugtest
A procedural control is included in the test. A color line appearing in the control region (C) is con-
sidered an internal procedural control. It confirms sufficient specimen volume, adequate membra-
ne wicking and correct procedural technique.
1. The SalivaScreen Oral Fluid Drug Test Device provides only a qualitative, preliminary
analytical result. A secondary analytical method must be used to obtain a confirmed result.
Gas chromatography/mass spectrometry (GC/MS) or gas chromatography/tandem mass
spectrometry (GC/MS/MS) is preferred confirmatory methods.
2. A positive test result does not indicate the concentration of drug in the specimen or the route
of administration.
3. A negative result may not necessarily indicate a drug-free specimen. Drug may be present in
the specimen below the cutoff level of the assay.
A phosphate-buffered saline (PBS) pool was spiked with drugs to target concentrations of ± 50%
cut-off and ± 25% cut-off and tested with the SalivaScreen Oral Fluid Drug Test Device. The
results are summarized below.
Drug Concentration
Drug Concentration
*MTD: under development OPI
Drug Concentration
Drug Concentration
Saliva Direct CupOral Fluid Drugtest
The following table lists the concentration of compounds (ng/mL) above which the SalivaScreen
Oral Fluid Drug Test Device for AMP/MET/COC/OPI/THC/BZD identified positive results at a read
time of 10 minutes.
AMPHETAMINE (AMP)
Diacetylmorphine (Heroin)
b-Phenylethylamine
6-Monoacetylmorphine
Morphine 3-b-D-Glucuronide
p-Hydroxyamphetamine
METHAMPHETAMINE (MET)
D-Methamphetamine
(1R,2S) Å (-) Ephedrine
Methoxyphenamine
11-Nor-D9-THC-9 COOH
Methylenedioxymethamphetamin 50
11-Nor-D8-THC-9 COOH
BENZODIAZEPINES (BZD)
Benzoylecogonine
Chlordiazepoxide
Ecgonine methyl ester

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